Sanofi Life Sciences Vacancies For MSc, PhD Candidates – Apply Online
Sanofi Life Sciences Vacancies For MSc, PhD Candidates – Apply Online. MSc, PhD job at Sanofi. Interested and eligible applicants can check out all of the details on the same below
Hey guys for those of you who are interested in applying for a Senior Medical Regulatory Writer job opportunity at Sanofi, then check out all of the possible interview questions listed below.
Job Title: Senior Medical Regulatory Writer
Job ID: R2674080
Location: Hyderabad, India
Contract Type: Full time
Main responsibilities:
Write and/or edit high-quality clinical and safety documents, medical sections of Periodic Benefit-Risk Evaluation Reports, Addendum to clinical overviews, Clinical Study Reports (CSR), ID Cards, and evaluation reports, with added knowledge and expertise.Delivery of high-quality medical documents on time and in compliance with internal and external standards.
Essential Job duties and responsibilities:
- Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.
- Develops and maintains TA expertise.
- Reviews content created by peers’ writers.
- Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, and Pharmacovigilance teams.
- People:
1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement.
2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise. - Performance: Provide deliverables (PBRER, ACO, CSR, ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, Medical section of CTA) as per agreed timelines and quality
- Process:
1) Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported.
2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.
3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region.
4) Work with selected vendors within the region to deliver the required deliverables as per the defined process.
5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. - Stakeholders:
1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables.
2) Liaise with the Medical department to prepare relevant & customized deliverables. - Experience:>5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry
- Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment
- Technical skills: As applicable (Including but not limited toMedical operational excellence, time, and risk management skills,Excellent technical (medical) editing and writing skills)
- Education: Advanced degree in life sciences/ pharmacy/ similar discipline or medical degree (Ph.D. – master’s in science)
- Languages: Excellent knowledge of the English language (spoken and written)
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Hey guys for those of you who are interested in applying for a Senior Medical Regulatory Writer job opportunity at Sanofi, then check out all of the possible interview questions listed below.
- Can you describe your experience in writing and editing high-quality clinical and safety documents in compliance with internal and external standards? Sample Answer: Over the past five years, I have been extensively involved in writing and editing clinical and safety documents within the pharmaceutical industry. I have a strong understanding of regulatory requirements and guidelines, and I consistently ensure that the documents I produce meet the highest quality standards. I have experience in writing Periodic Benefit-Risk Evaluation Reports, Clinical Study Reports, and evaluation reports, among others, adhering to internal and external standards.
- How do you ensure the timely delivery of medical documents while maintaining compliance with internal and external standards? Sample Answer: Time management is crucial in my role as a medical regulatory writer. I prioritize my tasks based on deadlines, set realistic timelines, and plan my work effectively. Additionally, I maintain open communication with relevant stakeholders, such as scientific communication and pharmacovigilance teams, to align on project timelines and ensure a smooth workflow. Adhering to internal and external standards is ingrained in my work process, and I take meticulous care to ensure compliance throughout the document creation process.
- Can you provide an example of how you have collaborated effectively with global or local teams, such as scientific communication and medical regulatory writing teams, to develop medical documents? Sample Answer: Collaboration is essential in the field of medical regulatory writing. In my previous roles, I have actively collaborated with global and local teams to develop medical documents. For example, I have worked closely with scientific communication teams to ensure accurate representation of scientific data in the documents. I have also collaborated with medical regulatory writing teams to align on writing style, adhere to guidelines, and maintain consistency across documents. Effective communication and teamwork have been key factors in achieving successful outcomes.
- How do you stay updated on regulatory requirements and maintain expertise in the field of medical regulatory writing? Sample Answer: As a medical regulatory writer, staying updated on regulatory requirements is crucial. I regularly engage in continuous learning through participation in regulatory workshops, attending conferences, and keeping abreast of relevant industry publications and guidelines. I also actively collaborate with colleagues and industry networks to exchange knowledge and stay informed about regulatory changes. By proactively seeking new information and maintaining a strong professional network, I ensure that my expertise in medical regulatory writing remains up to date.
- Can you explain how you manage stakeholder relationships, particularly with the medical scientific community, to develop medical regulatory content as per requirements? Sample Answer: Building and maintaining effective stakeholder relationships is essential in developing medical regulatory content. I actively engage with the medical scientific community to understand their needs, gather feedback, and ensure that the content aligns with their requirements. I establish open lines of communication, seek their input during the content development process, and address any concerns or queries they may have. By fostering strong relationships and actively involving stakeholders, I can develop medical regulatory content that meets their expectations.
Remember to personalize your answers based on your own experiences and skills. These sample answers are provided as reference points. Good luck with your interview!
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